Senior Medical Director, Clinical Development, Ophthalmology

Senior Medical Director – Ophthalmology

The Senior Medical Director will play a key role in clinical development programs within the Ophthalmology portfolio, being accountable for program deliverables, supporting resourcing, budget, and timelines. This role serves as scientific and medical lead for clinical teams working closely with operational leads and requires a high-performing, passionate individual who demonstrates outstanding clinical scientific knowledge.

Responsibilities

• Accountable for deliverables of assigned program(s) and for supporting resourcing, budget, and timelines of these programs.
• Serve as scientific and medical lead for clinical team(s) working closely with operational leads.
• Collaborate with multi‑disciplinary clinical teams to guide and execute clinical development strategies and regulatory submissions.
• Lead the design and execution of first‑in‑human through registration‑enabling studies.
• Represent the organization to internal leaders, development partners, and U.S. and global regulatory agencies.
• Act as medical expert and leader in interactions with external stakeholders (regulatory authorities, key opinion leaders, advisory boards) and internal stakeholders (Research, Global Clinical Development, Global Medical Affairs, Marketing, HEOR) as well as internal decision boards.
• Develop unique and innovative clinical strategies to significantly shorten the development cycle.
• Design and develop more efficient and innovative, yet robust Phase1,2, and3 programs.
• Provide input on next‑generation target development in collaboration with research and discovery teams.
• Ensure drug safety, including patient safety aspects in clinical studies and signal detection from post‑marketing surveillance, supported by Global Patient Safety.
• Ensure quality of all clinical documents (investigators' brochure, protocol, study report, clinical components of regulatory submissions, safety‑related documents).
• Develop written responses to regulatory agency questions and prepare regulatory submission documents.
• Demonstrate strong consensus‑building skills and collaborative ability with multi‑disciplinary teams.
• Serve as a key member of dynamic, matrixed clinical teams in a fast‑paced, hands‑on environment.

Qualifications

• A M.D., D.O. or equivalent medical degree and relevant training.
• Trained Ophthalmologist who is board‑certified or eligible, or an equivalent qualification.
• Minimum of 4 years of industry experience in early or late clinical development (a strong academic background may compensate for less experience).
• Experience leading proof‑of‑concept and/or registrational clinical trials, including protocol design, managing study start‑up, directing and guiding study team execution, data cleaning, medical monitoring/review, and database locking.
• Solid knowledge of compliance and global regulatory requirements (ICH) for the development of pharmaceutical candidate products.
• Strong commitment to clinical research and ability to work well within a team setting.

Location and Compensation

4 days a week on‑site in Tarrytown, NY; Cambridge, MA; or Warren, NJ. Salary range: $333,300.00 – $450,900.00 annually.

EEO Statement

Regeneron is an equal‑opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.

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